The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop System

NCT05866900 | Unknown FDA Device

• 1 other identifier: CHOco-AID
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lifestyle factors, including diet, play an important role in the achievement of glycemic targets in patients with diabetes, even with the use of automated insulin delivery (AID) systems. Advanced hybrid closed-loop systems (AHCL), by implementing innovative and powerful control algorithms, have been shown to improve the post-meal glycemic control in their users through the delivery of automatic correction boluses. However, data about the influence of the daily amount of carbohydrate intake on glycemic outcomes in youth with type 1 diabetes using AHCL are missing. Therefore, this study will evaluate the association between daily carbohydrate intakes and meal patterns on glycemic control of young people living with type 1 diabetes using an AHCL system (Medtronic MiniMed 780G; Medtronic, Northridge, California) under real-life conditions.

Conditions

Diabetes Mellitus, Type 1

Keywords

MiniMed 780G; automated insulin delivery; nutrition; diet; time in range; insulin pump

Outcome Measures

Primary Outcomes (7)

• Time in range (%)

  Time spent with sensor glucose between 70 and 180 mg/dl (3.9 and 10 mmol/L)

  6 months

• Time above range level 1 (%)

  Time spent with sensor glucose between 180 and 250 mg/dl (10.1 and 13.9 mmol/L)

  6 months

• Time above range level 2 (%)

  Time spent with sensor glucose \> 250 mg/dl (13.9 mmol/L)

  6 months

• Time below range level 1 (%)

  Time spent with sensor glucose between 54 and 70 mg/dl (3.0 and 3.8 mmol/L)

  6 months

• Time below range level 2 (%)

  Time spent with sensor glucose \< 54 mg/dl (3.0 mmol/L)

  6 months

• Mean sensor glucose (mg/dl or mmol/L)

  6 months

• Coefficient of variation (%)

  6 months

Secondary Outcomes (3)

• BMI Z-score

  Baseline, 3 months, 6 months

• Weight Z-score

  Baseline, 3 months, 6 months

• Height Z-score

  Baseline, 3 months, 6 months

Interventions

MiniMed 780G with SmartGuard activated DEVICE

The MiniMed 780G system consists of a MiniMed 780G Insulin Pump connected to Guardian 4 Sensor or Guardian 3 Sensor, using an automated insulin delivery algorithm called SmartGuard.

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from electronical records of two Pediatric Diabetes departments located in Slovenia and Italy

You may qualify if:

• Patients with type 1 diabetes
• Patients aged 7-18 years
• Patients using Medtronic MiniMed 780G with SmartGuard activated
• Patients whose informed consent has been obtained
• \>70% CGM data during observational period

You may not qualify if:

• Patients with partial clinical remission according to the Hvidovre Study Group definition
• Concomitant treatment with steroids or other drugs known to interfere with blood glucose levels
• Previous diagnosis of psychological or eating disorders

Sponsors & Collaborators

• University of Ljubljana, Faculty of Medicine: lead
• University of Messina: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Klemen Dovc, MD, PHD

CONTACT

+38615229235; klemen.dovc@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: May 15, 2023
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05